Senior Clinical Research Associate - Remote- North Carolina

AbbVie•Raleigh, NC

1d•$96,500 - $183,500•Remote

About The Position

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. This role advances AbbVie's pipeline by striving for excellence in clinical research, turning science into medicine for our patients and leveraging advanced capabilities to drive industry leading performance. The Senior Clinical Research Associate partners with study teams, AbbVie internal R&D stakeholders, investigators, and site staff for meaningful and effective engagements positioning AbbVie as the partner of choice in clinical trials. The focus is on site clinical research that ensures appropriate conduct of the trial while driving improvement in data integrity, compliance, overall study performance and customer experience.

Requirements

Minimum of 3 years of clinically related experience, with at least 2 years in independent clinical research monitoring of investigational drug or device trials in any therapeutic area.
Familiar with risk-based monitoring approach, onsite and offsite monitoring.
Knowledge of appropriate therapeutic area indications with the ability to understand and apply scientific concepts as they relate to the conduct of clinical trials.
Superior knowledge of existing and emerging local regulatory and legal requirements, ICH/GCP Guidelines, and applicable policies.
Demonstrated advanced communication skills and superior cross-functional collaboration skills among internal and external stakeholders.
Demonstrated superior planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines.
Superior ability to leverage technology, tools, and resources to provide customer-centric support based on the health of the site.
Superior interpersonal skills with excellent written, verbal, active listening, and presentation skills, with the ability to establish and leverage site relationships and trusted partnerships through engagement, motivation, and training.
Ability to independently use functional expertise, leverage critical thinking skills, and apply good judgment to address clinical site issues.
Acts with integrity in accordance with AbbVie's code of business conduct and leadership values. Self-motivated individual focused on delivering timely and quality outcomes in a fast-paced environment.

Nice To Haves

Appropriate tertiary qualification in health-related disciplines (e.g., Medical, Scientific, Pharmacy, Nursing) preferred.

Responsibilities

Serves as the primary Sponsor point of contact for the investigative site, providing contextual information on clinical trials, connecting stakeholders to investigative sites, and strengthening AbbVie's positioning. Motivates and aligns the monitoring community through leadership and mentorship.
Aligns, trains, and motivates site staff and the principal investigator on the goals of the clinical trial program, protocol, and patient treatment principles, ensuring a trusted partnership. Supports, guides, and mentors junior personnel on Site Management activities.
Conducts site evaluation, site training, routine on-site and off-site monitoring, and site closure monitoring activities in compliance with the protocol and monitoring plans, applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and quality standards, ensuring the safety and protection of study subjects.
Develops and implements site engagement strategies, gathering local/site insights and utilizing site engagement tools to report/track progress and measure impact. Connects the study protocol, scientific principles, and clinical trial requirements to day-to-day clinical trial execution activities. Generates and ensures effective patient recruitment and retention techniques/plans based on the patient disease journey.
Develops solid knowledge of the therapeutic area, asset, and clinical landscape/patient journey to enable successful patient recruitment and overall protocol compliance.
Mentors and trains less experienced CRAs on various aspects of work and provides input into their development. Supports local onboarding of more junior CRAs. Demonstrates ability to openly listen to and consider viewpoints to enhance outcomes.
Participates/leads in global/local task forces and initiatives. Responsible for activities as assigned by manager.
Conducts continuous risk-assessment proactively, and in collaboration with the Central Monitoring team, monitors activities conducted by clinical sites to detect early overall study performance or patient safety issues. Resolves site risk signals while understanding site processes to drive study execution. Ensures preventative and corrective action plans are put into place to mitigate risk and promote compliance.
Independently identifies, evaluates, and recommends new/potential investigators/sites, demonstrating expert understanding and decision-making. Potential sites may be identified through networking or internal AbbVie requests.
Ensures the quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel. Ensures audit and regulatory inspection readiness at assigned clinical sites at all times. Manages investigator payments as per executed contract obligations, as applicable.